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Cryocompression for Gynecologic Cancer

N/A
Recruiting
Led By Laura Havrilesky
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or FNA in conjunction with radiologic impression will be eligible)
ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
Must not have
Treated with prior neurotoxic chemotherapeutic agents
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to two months after completion of chemotherapy, an average of 6 months
Awards & highlights

Summary

This trial will test if cryotherapy wraps plus compression therapy can help prevent chemo-caused nerve pain in women with gynecologic cancer. It'll also measure patient and staff satisfaction.

Who is the study for?
This trial is for patients with gynecologic cancers (like ovarian, cervical, endometrial) who are set to receive at least 6 cycles of paclitaxel chemotherapy every 3 weeks. They should be in good physical condition as indicated by an ECOG score of 0-1. Those with previous treatments that can affect nerves or existing conditions like diabetic neuropathy aren't eligible.
What is being tested?
The study is testing if using cryotherapy wraps with compression therapy (cryocompression) is as effective as cryotherapy alone in reducing nerve pain and damage caused by chemotherapy in gynecologic cancer patients. It also evaluates patient comfort and satisfaction with the treatment.
What are the potential side effects?
Potential side effects may include discomfort from the cold temperature of cryotherapy, possible skin irritation from compression wraps, and any unforeseen reactions related to combining these therapies during chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a type of gynecologic cancer.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with chemotherapy that can affect the nerves.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to two months after completion of chemotherapy, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to two months after completion of chemotherapy, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Functional Assessment of Cancer Therapy (FACT) -Taxane [FACT-NTX] (patient reported assessment) over time
Secondary study objectives
Acceptability: scale
Change in Patient Neurotoxicity Questionnaire [PNQ] (patient reported assessment) over time
Chemotherapy Dose
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: CryotherapyExperimental Treatment1 Intervention
Group II: Compression with CryotherapyExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Compression
2020
Completed Phase 4
~80
Cryotherapy
2011
Completed Phase 4
~2280

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,424 Previous Clinical Trials
3,065,894 Total Patients Enrolled
Laura HavrileskyPrincipal InvestigatorDUHS
1 Previous Clinical Trials
~127 spots leftby Jan 2027
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